Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Lamictal(R)
Date:11/12/2007

DETROIT, Nov. 12 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., (Amex: CPD) announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Lamotrigine Tablets (lamotrigine), 25 mg, 100 mg, 150 mg, and 200 mg. Final approval to market this product is anticipated subsequent to the expiry of patent protection on January 22, 2009.

Lamotrigine is indicated as adjunctive therapy for partial seizures (the generalized seizures of Lennox-Gastaut syndrome), is indicated for conversion to monotherapy in adults with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED, and is indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy.

This tentative approval is the bioequivalent to Lamictal(R), a registered trademark of GlaxoSmithKline. Lamictal(R) tablets had U.S. sales of approximately $1.89 billion for the 12-month period ended September 30, 2007, according to IMS Data.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are extremely pleased to receive this tentative approval and look forward to the expiration date of the patent in January 2009, which will allow Caraco to market the product. We feel that generic Lamictal(R) will be a positive addition to our portfolio by expanding our product offerings."

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.

Safe Harbor: This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. These risks and uncertainties are contained in the Corporation's filings with the Securities and Exchange Commission and include, but are not limited to: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or cheaper products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, and other risks identified in this report and from time to time in our periodic reports and registration statements. These forward- looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.


'/>"/>
SOURCE Caraco Pharmaceutical Laboratories, Ltd.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
2. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
3. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Coreg(R)
4. Caraco Pharmaceutical Laboratories Ltd. Announces Tentative FDA Approval for Generic Zyrtec Chewable(R)
5. Caraco Pharmaceutical Laboratories Ltd. Reports Record Net Sales for the Second Quarter and First Six Months of Fiscal 2008
6. Mylan Commences Tender Offers and Consent Solicitations for Its 5.750% Senior Notes Due 2010 and 6.375% Senior Notes Due 2015 in Connection With Its Proposed Acquisition of Mercks Generic Pharmaceutical Business
7. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
8. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
9. National Pharmaceutical Council Announces New Strategic Focus, Search for New Leadership
10. Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial for Metastatic Melanoma
11. Par Pharmaceutical Files Form 10-K for 2006 -- Company to Hold First Analysts Meeting September 28, 2007
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/17/2017)... ... 17, 2017 , ... Peoples Health is pleased to announce ... Dec. 1, 2016. Peoples Health, a Metairie-based Medicare Advantage company, serves more than ... to our provider network, and the addition will benefit our members in the ...
(Date:1/17/2017)... ... January 17, 2017 , ... A prescription medication bottle, pocket knife, luggage and ... to Cradle Product Design Challenge , the Cradle to Cradle Products Innovation Institute ... design challenges scheduled to run through early 2018. The challenges are presented by the ...
(Date:1/17/2017)... (PRWEB) , ... January 17, 2017 , ... Neil H. ... financial planning assistance to communities throughout the region, is launching a charity drive to ... disease is by far the deadliest killer in America, and is responsible for 1 ...
(Date:1/17/2017)... ... January 17, 2017 , ... SC&H Group, a leading ... a Principal in its IT Advisory Services practice . Rossi is the third ... market demand for strategic IT guidance grows, and the practice continues to expand.     , ...
(Date:1/17/2017)... ... January 17, 2017 , ... ... and eliminate cyber threats in real-time, today announced a strategic partnership with ... Selangor, Malaysia. Joining other Seceon partners, TechLab Security has become a strategic partner ...
Breaking Medicine News(10 mins):
(Date:1/17/2017)... -- Edwards Lifesciences Corporation (NYSE: EW ), the ... and critical care monitoring, plans to announce its operating ... the market closes on Wednesday, February 1, 2017, and ... that day to discuss those results. To ... (201) 689-8037.  For 72 hours following the call, an ...
(Date:1/17/2017)... PUNE, India , Jan. 17, 2017  Market Research Future ... Global Endoscopy Devices Market is expected to reach USD 33.6 million ... 2016. Market Highlights ... The Global Endoscopy Devices Market has been examined as ... rate. Globally there is huge demand for endoscopy device in various ...
(Date:1/17/2017)... Research and Markets has announced the addition of the ... offering. ... global fluoropolymer market in the healthcare industry to grow at a ... Fluoropolymer Market in the Healthcare Industry 2016-2020, has been prepared based ... report covers the market landscape and its growth prospects over the ...
Breaking Medicine Technology: